A Study of ATG-201 in Adult Participants With Autoimmune Diseases
ATTRACT
A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases
1 other identifier
interventional
149
1 country
22
Brief Summary
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2026
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2029
July 28, 2026
July 1, 2026
2.3 years
July 24, 2026
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and TolerabilitySafety and Tolerability
Incidence and severity of adverse events (AEs), CRS.
48 weeks
Other Outcomes (3)
To evaluate the PK of ATG-201
48 weeks
Detection of anti-drug antibodies
48 weeks
Change from baseline in B lymphocyte cell numbers in peripheral bloo
48 weeks
Study Arms (1)
ATG-201
EXPERIMENTALThis is a phase I, open-label, first-in-human clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of ATG-201 in participants with autoimmune diseases. The study will be conducted in 2 parts: Dose Escalation (Part I) and Dose Expansion (Part II). Part I (Dose Escalation) consists of 2 dosing stages: Single Ascending Dose (SAD) and Step-Up Dose (SUD). A total of 9 dose levels is preset: 0.01 μg/kg, 0.2 μg/kg, 3 μg/kg, 10 μg/kg, 30 μg/kg, 100 μg/kg, 300 μg/kg, 900 μg/kg, and 1500 μg/kg. In Part II (Dose Expansion), the OBD(s) will be further explored and evaluated in 2 selected indications out of SLE, SSc and SjD.
Interventions
ATG-201 is a recombinant, human IgG1-like TCE that simultaneously binds to human CD3 and CD19. The primary packaging used for ATG-201 injection consists of 2 mL middle-boro injection vial (2 mL-Pro), sealed with 13 mm stopper gray with B2 coating and 13 FO LQ 3769 blue cap. The production specification is 20 mg/vial.
Eligibility Criteria
You may qualify if:
- Participants who give consent to this study participation and sign informed consent form.
- Participants at least 18 years of age inclusive at screening visit.
- Must be able to adhere to the study visit schedule and other protocol .requirements.
- Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.
- Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.
- SLE: subjects:
- Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria at screening.
- Have active SLE disease.
- Have had previous treatment failure.
You may not qualify if:
- Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).
- Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.
- Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.
- Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
- History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant.
- Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.
- Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\>60 mg/day) within 2 months prior to screening.
- Live or attenuated vaccine within 28 days prior to screening or during screening.
- Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.
- The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Nanfang Hospital of Southern Medical Universit
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, China
Nuclear Industry General Hospital
Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2026
First Posted
July 28, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
July 28, 2026
Record last verified: 2026-07